A Phase I/Ib Study of AZD9150 (ISIS-STAT3Rx) in Patients With Advanced/Metastatic Hepatocellular Carcinoma

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Advanced Adult Hepatocellular Carcinoma

Hepatocellular Carcinoma Metastatic

Treatments

Drug: AZD9150

Study type

Interventional

Funder types

Industry

Identifiers

NCT01839604

D5660C00001

ISIS 481464 (Other Identifier)

Details and patient eligibility

About

This is a phase I/Ib open-label, multicentre study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of AZD9150 in patients with advanced/metastatic hepatocellular carcinoma.

Full description

A Phase I/Ib, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of AZD9150 in Patients with Advanced/Metastatic Hepatocellular Carcinoma.

Enrollment

58 patients

Sex

All

Ages

18 to 130 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Aged at least 18 years. Patient from Japan and Taiwan aged at least 20 years
Histologically or cytologically confirmed HCC (with the exception of fibrolamellar carcinoma or mixed variants of HCC with fibrolamellar histology OR clinically diagnosed HCC for patients with difficulty in obtaining histological diagnosis)
Relapsed, refractory, intolerant or unlikely to benefit from sorafenib (for example due to comorbidity)
Metastatic or locally advanced meeting ANY of the criteria below:
HCC not suitable to receive local therapy
Disease recurred or was refractory to last therapy (local or systemic)
Eastern Cooperative Oncology Group (ECOG) performance status 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 8 weeks

Exclusion criteria

More than 2 prior systemic treatments for HCC
Prior grade 3 hematologic toxicity related to treatment with a JAK or STAT3 inhibitor
Presence of hepatic encephalopathy within 4 weeks of 1st dose
Uncontrolled massive ascites
High likelihood of bleeding